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Clinical Trial Summary

The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 20 mg tablets (test) and Paxil® (reference) administered as 20 mg tablet under fed conditions.


Clinical Trial Description

The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 14 days. During each session, the subjects will be administered a single dose of 20 mg Paroxetine (one Paroxetine Hydrochloride Tablet 20mg or one Paxil® Tablet 20 mg) under Fasting and Fed conditions. Venous blood samples will be collected at pre-dose (0 h), and up to 96 h post dose. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03504475
Study type Interventional
Source Beijing Tongren Hospital
Contact
Status Completed
Phase Phase 1
Start date March 29, 2018
Completion date June 16, 2018

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